Reported Sep 14, 2022 · Ongoing
Product Description/Item: ChemoLock Bag Spike, 10 units/CL-10-10; ChemoLock BAG SPIKE w/ ADDITIVE PORT, DRY…
ICU Medical, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: ICU Medical, Inc. · 951 Calle Amanecer · San Clemente, CA · 92673-6212
Is this the product you have?
- Product Description/ItemChemoLock Bag Spike, 10 units/CL-10-10; ChemoLock BAG SPIKE w/ ADDITIVE PORT, DRY SPIKE/CL-12; APPX 1.5ml,ChemoLock BAG SPIKE WITH ADDITIVE PORT/CL-13; ChemoLock Port/CL2100; ChemoLock Port, 5 Units/CL2100-5; ChemoLock Port/CL2100T; Clave Bag Spike w ChemoLock Port/CL2150; 30" (76 cm) Appx 3.3 ml, 20 Drop Admin Set w Integrated ChemoLock Drip Chamber, Spiros w/Red Cap, Hanger/CL3011; 9 IN(23cm)APPX 2.7ml,EXT SET,ChemoLock PORT,2 CLAMPS,2 GRADUATED CONN/CL3364; Syringe Transfer Set w Clave, ChemoLock Port/CL-34; 30" (76 cm) Appx 3.6 ml, 20 Drop Admin Set w Integrated ChemoLock Port Drip Chamber, ChemoLock w Red Cap, Bag Hanger/CL3511; 30" (76 cm) Appx 3.6 ml, 20 Drop Admin Set w Integrated ChemoLock Port Drip Chamber, ChemoLock w Red Cap, Bag Hanger/CL3511T; 30" (76cm) Appx 6.3 ml, 20 Drop Admin Set w Integrated ChemoLock Port Drip Chamber, 0.2 Micron Filter, ChemoLock w Red Cap, Hanger/CL3528; 7" (18 cm) Appx .93 ml, Ext Set w/ChemoLock, Y-Connector, Rotating Luer/CL3535T; Oncology Kit w/5" (13 cm) Add-On Set w ChemoLock Additive Port, Vented Cap, ChemoLock, Spinning Spiros w Red Cap/CL3538; Graduated Connector w ChemoLock Port/CL3900; ONCOLOGY KIT, EXT,ChemoLock PORT, GRAD CONN,TRANSFER,ChemoLock,VIAL SPIKE,ChemoLock PORT/CL3927; Oncology Kit w 5" (13 cm) Add-On Set w ChemoLock w Red Cap, Vented Cap, ChemoLock Port w Bag Spike, Spiros w Red Cap/CL3946; Oncology Kit w 17" (43 cm) Bifuse Ext Set w/ChemoLock w Red Cap, ChemoLock Port, ChemoLock Vented Vial Spike, 13mm ChemoLock/CL3947; Oncology Kit w ChemoLock Port Closed Vial Spike, ChemoLock, ChemoLock Port Bag Spike/CL3952; APPX 0.5ml, ChemoLock BAG SPIKE WITH ADDITIVE PORT,ChemoLock Port/CL3955
- Lot codes and dates
50 of 50 products
Products covered by this recall # Barcodes Product as published 1 10887709071022CL-10-10/10887709071022/5872839, 5891255 2 10887709056975CL-12/10887709056975/5819981, 5856055, 5873186 3 10887709056982CL-13/10887709056982/5850811 4 CL2100/5797867, 5816334, 5829882,5850510 5 10887709122960CL2100-5/10887709122960/5754377 6 10887709099293CL2100T/10887709099293/5816341, 5842229, 5850517 7 10887709094670CL2150/10887709094670/5829900, 5850507 8 10887709057019CL3011/10887709057019/5829885, 5842227 9 10887709073408CL3364/10887709073408/5841261, 5850805 10 10887709069777CL-34/10887709069777/5754437, 5829875 11 10887709057026CL3511/10887709057026/5842231, 5861991, 5894477 12 10887709120010CL3511T/10887709120010/5829831, 5891263 13 10887709057040CL3528/10887709057040/5850500, 5872833, 5883793, 5894481, 5909807 14 10887709099613CL3535T/10887709099613/5685350 15 10887709071909CL3538/10887709071909/5935851 16 10887709071411CL3900/10887709071411/5772697 17 10887709075440CL3927/10887709075440/5842211 18 10887709080291CL3946/10887709080291/5829895, 5861983 19 10887709080307CL3947/10887709080307/5782844 20 10887709081571CL3952/10887709081571/5782863,5816379 - Amount recalled
- 454,635
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Ports have a potential for unintended disconnection, inability to connect to or fully engage with injectors, due to a variation in the spring inside the Port, which may cause delay of therapy and exposure to caustic substances. Ports available as standalone connectors, or utilized as access points on vial adaptors, bag spikes, and administration sets.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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